Quality Management System Program Lead, Life Sciences

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Job Summary

Life Sciences' Quality Management System (QMS) Program Lead will be responsible for consistently guiding, advising, implementing, and supporting Life Sciences' quality management system (QMS) across its accounts. This Lead must effectively collaborate with JLL's Sr. Director of Quality & Compliance to ensure that best-in-class quality management system programs are effectively designed, implemented, followed, and continuously improved. This resource must have a strong and proven hands-on experience in quality management systems within the Life Sciences (Pharmaceutical, Biotechnology and/or Medical Devices) industry from an operations, facilities, engineering, and maintenance perspective.

A background and understanding of GxP regulations and current industry practices is strongly required. The resource must have a solid understanding of cGxPs as they relate to the performance of maintenance and repairs of equipment, facilities, utilities, and site support services such as pest control and cleaning/disinfection services. This position is expected to interface with each account's Quality Lead to ensure that all applicable procedures are followed, and that the work performed by the account is documented and recorded in JLL's QMS System following Good Documentation Practices. In addition, this position may be required to lead the Quality Management Scope of one, or multiple, small accounts.

The Quality Management System Program Lead must have a strong commitment to quality assurance, and a willingness to help support a quality first culture within the Life Sciences vertical. Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision.

Responsibilities

• Continuously look for opportunities to improve Life Sciences QMS and ISO 9001:2015 Certification programs.
• System owner and consistency driver of Life Sciences' QMS programs across its Accounts.
• Support implementation and improvement of a Quality Compliance Culture throughout JLL Life Sciences
• Prepare and provide status reports and presentations to Life Sciences' internal and external clients.
• Conduct audits and GAP assessment against the Quality Management Systems, Industry Regulations, ISO 9001, and Quality Agreements. This also includes the subsequent preparation of remediation recommendations and audit reports.
• Perform investigations of significant event deviations and/or customer complaints along with the identification of the sequence of events, impact assessment, trend evaluations, root cause analysis (RCA), contributing factors, and recommended corrective and preventive action (CAPA) plans.
• Management of Life Sciences' significant investigations, corrective and preventive actions (CAPA), change control, customer complaints, vendor management and continuous improvement logs and dashboards.
• Oversee Life Sciences' GxP Contractors compliance program (e.g., qualification, agreements, audits, performances, etc.)
• Seeks to continuously improve quality processes, systems and overall client satisfaction.
• Support potential opportunities identified by the Solutions Development group. This may include, developing the Quality & Compliance solutions of potential client bids.
• Provide quality and compliance guidance support to new account/scope transition processes to ensure that all identified quality deliverables are timely completed.
• Perform subject matter expert review of account specific quality agreements.
• Performs additional job duties as requests, analysis and reporting.

Position Requirements

• Bachelor of Science degree is desired with a minimum of 6 years of experience in quality/compliance, engineering, facilities, and/or production/facility operations. Equivalent experience, in lieu of Bachelor of Science degree, may be acceptable.
• EIT or Professional Engineer license a plus
• Knowledge of Quality Management Systems such as GAP Assessments, Remediation Planning, Audits, Investigations, RCAs, CAPAs, Vendor Qualification, and Quality Management Systems
• Strong working knowledge of computer applications and/or softwares, including MSOffice and GxP quality management systems.
• Experience with ISO 9001:2015 standards
• Proven record of excellent internal and external customer relation services
• Good oral and written communication skills including the ability communicate to all levels of management and interface with a diverse customer base including technical and non-technical personnel.
• Availability to travel with short notice.

This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship.

Estimated compensation for this position:

This range is an estimate and actual compensation may differ. Final compensation packages are determined by various considerations including but not limited to candidate qualifications, location, market conditions, and internal considerations.

Location:

If this job description resonates with you, we encourage you to apply, even if you don't meet all the requirements. We're interested in getting to know you and what you bring to the table!

Personalized benefits that support personal well-being and growth:

JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include:

• 401(k) plan with matching company contributions

• Comprehensive Medical, Dental & Vision Care

• Paid parental leave at 100% of salary

• Paid Time Off and Company Holidays

• Early access to earned wages through Daily Pay

At JLL, we harness the power of artificial intelligence (AI) to efficiently accelerate meaningful connections between candidates and opportunities. Using AI capabilities, we analyze your application for relevant skills, experiences, and qualifications to generate valuable insights about how your unique profile aligns with the specific requirements of the role you'repursuing.

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